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The Capnostream20 is intended for CO2 and SpO2 indications. The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2 and pulse rate). It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments.

The Capnostream10 is intended for CO2 indications only. The Capnostreamso is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and insoired breath. It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments.

Capnostream20: The Capnostream20 bedside monitor is a two parameter monitor consisting of an EtCO2 MiniMediCO2 module and a MP100 SpO2 module, displays and alarms.

Capnostream10: The Capnostream ( bedside monitor is a one parameter monitor consisting of a MP100 EtCO2 module displays and alarms.

The provided text describes information about the Capnostream20 and Capnostream10 devices but does not contain a study or data to prove that the devices meet acceptance criteria. Instead, it seems to be part of a 510(k) submission, establishing substantial equivalence to predicate devices. Therefore, I cannot generate the requested table and study summary based on the provided text.

However, I can extract information related to the device descriptions, intended use, and substantial equivalence:

Device Descriptions and Intended Use:

• Capnostream20: A two-parameter monitor consisting of an EtCO2 MiniMediCO2 module and an MP100 SpO2 module. It displays and provides alarms for continuous, non-invasive measurement and monitoring of carbon dioxide concentration of expired and inspired breath and respiration rate, and continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2 and pulse rate). Intended for neonatal, pediatric, and adult patients in various healthcare environments.
• Capnostream10: A one-parameter monitor consisting of a MiniMediCO2 EtCO2 module. It provides continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. Intended for neonatal, pediatric, and adult patients in various healthcare environments.

Substantial Equivalence Information (instead of study data):

The devices are presented as substantially equivalent to legally marketed predicate devices.

• CO2 Module (MiniMediCO2) used in Predicate Devices:
  • Oridion Polaris 2004, K040011
  • CAS Medical Systems, Inc Models 750c-2ms, 750cm-2ms, 750c-Nnl, 750cm with MiniMediCO2-V1 K050844
  • Larsen & Toubro Limited Star 50 Monitoring System K051608
• Pulse Oximeter Module, SpO2 Module (MP100) used in Predicate Devices:
  • NPB OxiMax Pulse Oximeter System With N-595 Pulse Oximeter, K012891
  • NPB Oximax N-550, K021090

To fulfill your request for acceptance criteria and a study proving device performance, the document would need to include details of specific performance metrics (e.g., accuracy, precision) tested against predetermined acceptance thresholds, along with the methodology and results of such testing. This information is not present in the provided text, which focuses on regulatory submission details and comparison to predicate devices.

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